Details for New Drug Application (NDA): 217738
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The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.
Summary for 217738
Tradename: | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM |
Applicant: | Sciegen Pharms Inc |
Ingredient: | esomeprazole magnesium; naproxen |
Patents: | 0 |
Pharmacology for NDA: 217738
Mechanism of Action | Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 217738
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 217738 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-437 | 50228-437-10 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-10) |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 217738 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-437 | 50228-437-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;375MG | ||||
Approval Date: | Oct 11, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE;500MG | ||||
Approval Date: | Oct 11, 2023 | TE: | AB | RLD: | No |
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